(158 days)
The EKOS PE Endovascular Device with CU 4.0 is indicated for the:
- Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- Infusion of solutions into the pulmonary arteries.
- Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EKOS PE Endovascular System consists of an EKOS PE Endovascular Device and CU4.0 (Control Unit 4.0 and Connector Interface Cables). The EKOS PE Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 20 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
The provided text is related to a 510(k) premarket notification for a medical device called the EKOS PE Endovascular Device with Control Unit 4.0. This document describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.
However, the information provided does not contain acceptance criteria or a study proving the device meets specific performance metrics in the way your request describes (e.g., using a test set with ground truth established by experts, MRMC studies, or standalone algorithm performance).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (EkoSonic Endovascular Device with CU4.0) through a comparison of technological characteristics and performance testing against internal specifications and external standards (like ISO and IEC).
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance (in the context of clinical efficacy or diagnostic accuracy, as implied by "device performance" in your prompt). The table provided in the document (Table 1) lists "Product Specification" and "Purpose" with "Pass" results, which are more akin to design verification tests rather than clinical performance metrics.
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The device described is an "Embolectomy Catheter" used for ultrasound-facilitated infusion of fluids (including thrombolytics) for the treatment of pulmonary embolism and in peripheral vasculature. It is a physical medical device, not a diagnostic algorithm or AI system that would typically require the detailed clinical validation studies you're asking about.
What the document does provide regarding performance:
The document includes a "Performance Data" section (Section VII) which states: "Testing has confirmed that the EKOS PE Endovascular Device functions as intended and is substantially equivalent to the predicate device."
It then presents Table 1: Testing Overview Supporting the EKOS PE Endovascular System. This table lists various engineering and safety-related tests, their purpose, and the outcome ("Pass" for both initial and accelerated aged conditions). These are verification and validation tests to ensure the device meets its design specifications and complies with relevant standards.
Table 1: Testing Overview Supporting the EKOS PE Endovascular System (from the document)
| Product Specification | Purpose | EKOS PE Endovascular Device (Subject Device) T = 0 | Accelerated Aged (T=3 Years) |
|---|---|---|---|
| Physical Dimensions | Verified dimensional compatibility and stability with the MSD and DDC. | Pass | Pass |
| Tip Shape | Verified tip conformity to ISO 10555-1 requirements. | Pass | Pass |
| Kink Resistance | Verified device can be used within the target vasculature. | Pass | Pass |
| Tensile Strength | Verified device conformity to ISO 10555-1 requirements. | Pass | Pass |
| Electrical Safety | Verified device conformity IEC 60601-1 and IEC 60601-1-2 requirements. | Pass | Pass |
| Acoustic Characteristics | Verified device met specified acoustic design requirements. | Pass | Pass |
| Radiopacity | Verified device can be viewed under standard imaging techniques. | Pass | Pass |
| Pressure Resistance | Verified device lumens conformity to ISO 10555-1. | Pass | Pass |
| Temperature Sensing | Verified the device temperature sensors met specified design and functional requirements. | Pass | Pass |
| Functional Life | Verified device met specified functional life requirements. | Pass | Pass |
| Biocompatibility | Verified the device met biocompatibility requirements per ISO 10993-1. | Pass | Pass |
| Sterilization | Verified the device met sterilization requirements per ISO 11135. | Pass | Pass |
| Shelf Life | Verified the device met functional requirements after a 3-year shelf life. | N/A. | Pass |
| System Integration with CU4.0 | Verified the device integrates with the control unit, specifically, its acoustic protocol and enabled temperature safety features. | Pass | N/A. |
The "acceptance criteria" here are generally that the device "Passed" these various engineering and safety tests, demonstrating it functions as intended and is safe for its intended use, aligning with the standards and the predicate device's characteristics. There's no further detail on the methodology of these "Pass" assessments (e.g., specific quantitative thresholds beyond meeting standard requirements).
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).